MAUDE Adverse Event Report: BECTON DICKINSON BD EXT¿ STABILIZED EXTENSION SET WITH NEARPORT¿ IV ACCESS; INTRAVASCULAR ADMINISTRATION SET

Model Number	DYNDTC5081
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd ext¿ stabilized extension set with nearport¿ iv access was found discolored from yellow to brown.The following information was provided by the initial reporter: "discoloration from yellow to brown".
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A complaint of set turning brown was received from the customer.114 unopened samples were returned for investigation.Through visual inspection, the customer complaint was confirmed.The female luer was discolored on all samples.A device history record review for model dyndtc5081 lot number 22125254 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 07dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this discoloration is related to the sterilization procedure which iv sets undergo to help ensure product sterility.These iv sets are sterilized by irradiation, which uses electron beam or gamma rays to produce a sterile and safe iv product per iso 11137-1 and iso 11137-2, international standards for the sterilization of health care products.These standards are recognized consensus standards by the fda, which are adhered to by bd to specify the requirements for the development, validation, and routine control of a radiation sterilization process.The irradiation process is known to modify polymers which causes some discoloring, depending on the applied radiation level (dose) and material choices.The degree or intensity of discoloration can also change over time, as it approaches shelf life, and under certain storage conditions such as high temperatures.Nonetheless, this type of discoloration is strictly cosmetic and does not affect the safety and functionality of the device as tested and sterilized.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD EXT¿ STABILIZED EXTENSION SET WITH NEARPORT¿ IV ACCESS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16847748
• Report Number: 2243072-2023-00715
• Device Sequence Number: 7576772
• Product Code: FPA
• UDI-Device Identifier: 10080196141913
• UDI-Public: 10080196141913
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: DYNDTC5081
• Device Catalogue Number: DYNDTC5081
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown